Mifepristone for early termination of pregnancy.

Not Applicable

Completed

• Conditions: Termination of first trimester pregnancy.; Reproductive Health and Childbirth - Abortion

• Registration Number: ACTRN12611001051932
• Lead Sponsor: Marie Stopes International Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 13000

Inclusion Criteria

Confirmed pregnancy up to 9 weeks gestation.
Informed consent.
No contraindications.
Must meet legal requirements for termination of pregnancy in the state where the service is provided.

Exclusion Criteria

More than 9 weeks since the last menstrual period (confirmed by ultrasound).
Known or suspected ectopic pregnancy.
Concomitant administration of anticoagulants or corticosteroids.
Adrenal failure, inherited porphyria or a haemorrhagic disorder.
Allergy to mifepristone or misoprostol.
Intrauterine device insitu
Pelvic infection

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of procedure failure as measured by pregnancy test and ultrasound.[14 to 21 days post treatment]

Secondary Outcome Measures

Name	Time	Method
patient preferences at follow up - completion of a patient questionnaire regarding patients experience of pain, bleeding and overall satisfaction with the procedure.[A follow up appointment occurs in the time period of 14 to 21 days post dosing and at that visit a patient questionnaire is completed.];incidence of adverse events - reported to clinic following treatment. Serious adverse events associated with the procedure include hemorrhage, retained products of conception and very rarely, infection.[Adverse events are monitored from day of treatment to follow up which is most often up to 14 to 21 days post treatment.]